25 October 2023
QPPV – this mysterious abbreviation identifies the most crucial person involved in the whole process of monitoring of safety of drug products, that is pharmacovigilance. Who can become the QPPV? What are his key responsibilities? Does each pharmaceutical company have to employ a QPPV?
16 October 2023
Animal testing has long been a crucial aspect of drug development, aiding researchers in understanding the safety and efficacy of potential treatments. However, the ethical concerns and scientific limitations associated with animal testing have prompted the scientific community to embrace the principles of “Replace, Reduce, Refine” (3Rs) to minimize the use of animals and enhance the quality of research in this field.
09 October 2023
The safety measures taken to stop the pandemic in the years 2020-2021 have had a significant impact on our lives. Society had to confront lifestyle changes, uncertainty about the future. It is frightening that suicide attempts among children have increased several times compared to the pre-pandemic level. Check what the results of scientific research say about how drastically the level of mental health in our society has decreased and find out how you can help yourself and your loved ones.
02 August 2023
Nowadays it is difficult to imagine an economic entity functioning without using any form of advertisement. What about medicinal products? Do life-saving and life-enhancing products also need advertising? Do medicines which have pervaded our daily lives need to be additionally advertised? Stay informed with the latest medicinal products advertisement regulations and best practices. Read now for expert insights and guidance.
20 July 2023
In 2012 the medical and patient world held its breath because of Sanofi’s new product launch – Zaltrap (afibercept), a medicinal product registered for the treatment of colon cancer and its price of 9600 $/month. The price of Avastin (bevacizumab), its closest competitor, was half of its price, since Sanofi’s treatment was so expensive, oncologists turned down the idea of using it. Nowadays, even smaller brands don’t hesitate to spend money for reliable recognition of the market. Does this problem also apply to generic drugs? It may seem that the introduction of a generic drug will guarantee market success. Therefore, is there anything to be afraid of? Is there any risk, anything can go wrong?
12 July 2023
Every day, a lot of people experience side effects after using cosmetics, but not everyone knows that they can report them to the responsible authorities. Why reporting adverse reactions is important and how it affects the safety of cosmetics? If you want to find out what cosmetovigilance is – we invite you to read the article.
12 May 2023
Like every medicinal product, also an ATMP has to be well described prior each clinical trial. Hence, it is necessary to prepare a complete set of relevant documents required by law and then obtain approval for the clinical trial issued by the respective national agency. Explore the crucial steps of preparing an Investigational Medicinal Product Dossier (IMPD) for Advanced Therapy Medicinal Products (ATMP) as they progress into clinical trials.
13 April 2023
Safety management is key to any clinical trial and an utmost obligation to any pharmaceutical company introducing new medicinal products to the market. Whilst conducting a clinical trial, safety of all subjects is paramount, therefore best efforts should be made to capture any safety issues. All safety aspects have to be analyzed in the study […]
01 March 2023
As soon as the MA has been granted for the medicinal product, the MAH is responsible for the product’s quality, efficacy and safety. Therefore, the MAH is obliged to comply with national and European legislation. It is important to remember that depending on the country in which the medicinal product has obtained the MA, the […]
01 February 2023
Each drug developer at some point reaches the moment when it is necessary to run a clinical trial, and has to ask themselves where to test the developed medicinal product. However, there is no easy and straightforward answer as there are no formal limits in choosing the country. In this article we would like to […]
18 January 2023
Have you heard about the new version of the ICH Q3D Guideline for Elemental Impurities? Do you know, it was adopted on 24 March 2022 by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA), published on 2 May 2022 and came into force on 24 September 2022. The […]
06 December 2022
Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. It is essential to monitor post-authorisation safety of medicines to gather all safety data from a large number of various patients with numerous conditions and concomitant therapies using the drug for a […]